NCT00487123

Brief Summary

This study will evaluate the efficacy of the reminder device Remind Cap® in improving patients' compliance in the consumption of Valsartan +/- Hydrochlorothiazide (HCTZ) in the treatment of hypertension

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

First QC Date

June 13, 2007

Last Update Submit

June 13, 2008

Conditions

Hypertension

Keywords

Hypertension, compliance, Valsartan, hydrochlorothiazide (HCTZ)

Outcome Measures

Primary Outcomes (1)

  • Compliance rate at month 3, 6 and post study month 1 will be assessed by pill count

Secondary Outcomes (1)

  • Patient Adherence to study/follow up visits -Clinical Outcome Measurement: Mean sitting systolic BP and mean sitting diastolic BP -Patient's and Physician's Satisfaction Survey

Interventions

Valsartan+/- HydrochlorothiazideDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hypertension that have newly started using Valsartan+/-HCTZ

You may not qualify if:

  • Pregnancy or Hypersensitivity to Valsartan+/-HCTZ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Singapore, Singapore

Location

MeSH Terms

Conditions

HypertensionPatient Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • non IND

    Sponsor GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 13, 2007

First Posted

June 15, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

SG(1)